US CMS issues new code to track use of radiolucent porous interbody fusion devices

20th June 2017

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Vertera Spine’s Cohere device, comprised of porous PEEK

The US Centers for Medicare & Medicaid Services (CMS) has issued a new ICD-10 code (10th revision of the International Statistical Classification of Diseases and Related Health Problems, US variant) for a radiolucent porous interbody fusion device. The new classification is intended to enable healthcare providers and payers to selectively track the utilisation, outcomes and healthcare costs associated with this unique technology class.

According to a company release, Vertera Spine’s Cohere cervical interbody fusion device is the first and only clinically-available porous fusion device manufactured from polyether ether ketone (PEEK), and is approved for use under the new code. The IDC-10 code will come into effect on 1 October 2017 as an XRG code and is listed as “Interbody Fusion Device, Radiolucent Porous.”

Spinal interbody fusion devices have traditionally been classified by the implant material, either synthetic or tissue-derived alternative (eg. autograft and allograft). However, as more advanced orthopaedic biomaterials are developed, the use of a single coding identifier for all synthetic devices may no longer be appropriate for accurately describing fusion procedures, the press release states. Basic science, preclinical and clinical research have shown that porous PEEK possesses several performance characteristics that distinguish it from other fusion devices by combining the osseointegration capabilities of porous metallic devices with the favourable imaging properties of non-porous plastic devices. According to the Vertera Spine release, this combination of device attributes was introduced with US Food and Drug Administration (FDA) clearance of the Cohere device, prompting the issuance of the new ICD-10 code by CMS.

In addition to serving as a tracking method for healthcare payers and providers, the ICD-10 code may assist spine surgeons in clearly identifying the best options for patients.

“The issuance of this new code signifies the unique performance of porous PEEK devices compared with other fusion devices and the importance of monitoring how this technology impacts healthcare,” states Richard Guyer, Texas Back Institute, Plano, USA.

Kevin Foley, Semmes-Murphey Neurologic and Spine Institute, Memphis, USA, says, “The development of porous PEEK has allowed for the combination of radiolucency and porosity in an interbody implant that is completely plastic. In vivo studies have demonstrated that bone will grow into porous implants, improving their osseointegration. Until now, the only porous implants clinically available were made of metal or had a metallic coating, which can limit the surgeon’s ability to assess fusion on imaging. This new code gives us the potential to better correlate bony tissue ingrowth into Vertera Spine’s porous PEEK Cohere device with clinical outcomes.”

Erik Westerlund, St Francis Spine Center, Columbus, USA, states, “I began to see my one year follow-up Cohere device patients in May of this year, and the results have shown a clear and consistent trend of rapid and readily visible progression to robust osseous union. Not only is there characteristic radiographically visible osseous incorporation at the interconnected porous margin of the Cohere PEEK spacers, there is also a notable continuity of bridging bone across the entire interspace. The grant of a new specific ICD-10 code for porous PEEK will provide myself and other spine surgeons greatly refined capacity to track clinical outcomes and cost savings.”

Intended for use in anterior cervical fusion surgery, Cohere contains a three-dimensional porous architecture on its bone-contacting sides that is specifically designed and optimised to promote cellular bone formation and effectively form a strong interface with bone. Unlike some porous treatments that are coated onto the device, Cohere’s porous architecture is grown directly from the solid PEEK implant using a proprietary processing method that is designed to allow for bone tissue ingrowth on the surface, while retaining strength and durability.